Study 117113: Mepolizumab vs. Placebo as add-on treatment for frequently exacerbating COPD patients characterized by eosinophil level

Phase 3

Completed

Conditions: COPD
chronic obstructive pulmonary disease
10038716

Registration Number: NL-OMON44215

Lead Sponsor: GlaxoSmithKline

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 38

Inclusion Criteria

* Clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society/European Respiratory Society.
* Pre and post-salbutamol FEV1/FVC ratio of <0.70 at visit 1 and post-salbutamol FEV1> 20% and *80% of predicted.
* At least two moderate COPD exacerbations or at least one severe COPD exacerbation in the 12 months prior to visit 1. See protocol page 27-28 for details.
* A well documented requirement for optimized standard of care background therapy that includes ICS plus 2 additional COPD medications (i.e., triple therapy) for the 12 months prior to visit 1. See protocol page 28 for details.
* Males and females 40 years and above.
* Current smoger, ex-smoker or never smoker. See protocol page 28-29 for details.

Exclusion Criteria

* Asthma and other respiratory disorders. See protocol page 29 for details.
* Pneumonia, exacerbation, lower respiratory infection within the 4 weeks prior to visit 1.
* Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to visit 1.
* Other conditions that could lead to elevated eosinophils.
* Known, pre-existing parasitic infestation within 6 months prior to Visit 1
* Previous participation in any study of mepolizumab and received Investigational Product.
* Pregnancy or breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Frequency of moderate to severe exacerbations.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to first moderate/severe exacerbation. Frequency of COPD exacerbations<br /><br>requiring emergency department visits and/or hospitalizations. Change from<br /><br>baseline mean total St. George*s Respiratory Questionnaire-COPD (SGRQ-C) score.<br /><br>Change from baseline COPD assessment test (CAT) score.</p><br>